DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Examiner Assignment
This application has been transferred from Examiner Young J Kim to Examiner Tian Yu. All future correspondence should be directed to Examiner Tian Yu whose contact information appears at the end of this Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/28/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
This office action is in response to Applicant's Response to Election / Restriction filed on May 08, 2026.
Claims 1-3 and 5-10 are currently pending, with claims 1, 3 and 9 withdrawn.
Claims 2, 5-8 and 10 are under examination. This is the first action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 2, 5-8 and 10) in the reply filed on May 08, 2026 is acknowledged 1. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a).
Claims 1, 3 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Examination on the merits commences on claims 2, 5-8 and 10.
Priority
The effective filling date of the instant claims 2, 5-8 and 10 is 12/28/2023, the filling date of the instant U.S. nonprovisional application.
English Translation of Foreign Priority Application: Applicant's claim to foreign priority to the CHINA 202211719841.9 application is acknowledged. However, English translations has not been submitted.
The foreign priority date may be the effective filing date of the claimed invention if:
• the foreign application supports the claimed invention under 35 U.S.C. 112(a), AND
• the applicant has perfected the right of priority by providing a certified copy of the priority application, and a translation of the certified copy (if not in English) along with a statement that the translation of the certified copy is accurate.
See MPEP 213.04 and 216; See also MPEP 2304.01(c)
In this instant case, applicant has NOT perfected the right of priority by providing a translation of the certified copy. Without an English translation, the examiner is unable to verify whether the earlier applications provide written description support for the claimed invention under 35 U.S.C. 112(a). Thus, the effective filing date (EFD) of the claimed invention is the filing date of the instant US application.
However, if applicant perfects the right of priority by providing an English translations of the priority applications, along with a statement that the translation of the certified copy is accurate, that supports the claimed invention under 35 U.S.C. 112(a), the effective filing date will be the filing date of the foreign application.
Claim Objections
Claims 5-8 are objected to because of the following informalities:
In claim 5, lines 3-7, to improve consistency within the claim, it should read:
“testing genomic DNA of a test sturgeon germplasm for the sturgeon germplasm molecular marker, and determining the test sturgeon germplasm is the sturgeon germplasm of interest,
wherein the sturgeon germplasm of interest is Huso dauricus or a hybrid of Huso dauricus and other sturgeons. “
In claim 6, lines 2-4, to improve consistency within the claim, it should read:
“performing PCR amplification with the genomic DNA of the test sturgeon germplasm as a template by using a Hdau216p primer pair,
determining that the test sturgeon germplasm is the sturgeon germplasm of interest by obtaining an 216bp amplification product by the Hdau216p primer pair.”
In claim 7, lines 2-5, to improve consistency within the claim, it should read:
“performing PCR amplification with the genomic DNA of the test sturgeon germplasm as a template by using a Hdau1951 primer pair,
determining that the test sturgeon germplasm is the sturgeon germplasm of interest by obtaining an 195bp amplification product by the Hdau1951 primer pair.”
In claim 8, lines 2-5, to improve consistency within the claim, it should read:
“performing PCR amplification with the genomic DNA of the test sturgeon germplasm as a template by using a Hdau1951 primer pair,
determining that the test sturgeon germplasm is the sturgeon germplasm of interest by obtaining a 195bp amplification product and a 145bp amplification product.”
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, claim 2 recites the term "sturgeon germplasm," which is not expressly defined in the specification.
Under BRI and based on the commonly understood meaning 2, "germplasm" is interpreted to encompass germ cells and their precursors.
For the purpose of applying prior art, claim 2 recites "a molecule having a nucleotide sequence of more than 3 consecutive nucleotides at a terminal of the DNA molecule of SEO ID NO: 1." This molecule is interpreted as comprising SEQ ID NO: 1 with more than three additional consecutive nucleotides at a terminus of SEQ ID NO:1.
For the purpose of applying prior art, Claim 8 recites: "wherein the 195bp amplification product and the 145bp amplification product are the sturgeon germplasm molecular markers. "
This limitation is interpreted, in light of the specification to mean that the two amplification products are indicative of the presence or absence, in genomic DNA, of the molecular marker relating to SEQ ID NO: 1 as described in base claim 2.
This interpretation is made in view of the use of "molecular markers" in plural form, and the fact that FIG. 3 of the specification shows that the 145bp amplification product does not comprise any sequence of SEQ ID NO:1 (indicated as the 50bp insertion in FIG. 3). Thus, the 145bp amplification product cannot be the sturgeon germplasm molecular marker referred to in claim 2. Instead, it is interpreted as an additional marker indicating the absence of SEQ ID NO: 1 in the tested genome.
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Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 2 recites:
A method for identifying a sturgeon germplasm of Interest, comprising
using a sturgeon germplasm molecular marker and identifying a sturgeon germplasm of interest based on the sturgeon germplasm molecular marker,
wherein the sturgeon germplasm of interest is Huso dauricus or a hybrid of Huso dauricus and other sturgeons, and
the sturgeon germplasm molecular marker is a DNA molecule of SEO ID NO: 1,
a molecule having a nucleotide sequence of more than 10 consecutive nucleotides in the DNA molecule of SEO ID NO: 1, or
a molecule having a nucleotide sequence of more than 3 consecutive nucleotides at a terminal of the DNA molecule of SEO ID NO: 1.
Therefore, under BRI claim 2 is drawn to a method of identifying species information of sturgeon germplasm based on a DNA biomarker.
Following the analysis below the claims are not patent eligible under 35 U.S.C. 101.
Step 1 - Whether the Claim is to a Statutory Category : YES. The claims are drawn to a method, therefore to one of the four statutory categories.
Step 2A Prong 1 - Whether the Claim Recite an Abstract idea, Law of Nature, or Natural Phenomenon: Yes.
The claim recites a judicial exception, namely a law of nature of natural phenomenon. Specifically, the claim is directed to the naturally occurring DNA sequence found in the germplasm of Huso dauricus.
In the specification, the inventors describe observing an insertion naturally found in the genome of Huso dauricus ([0025]), and conclude that Huso dauricus and its hybrids can be identified based on this observed natural phenomenon.
As stated in MPEP 2106.04(b)(I), laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
In this instant case, the judicial exception is the natural phenomena of a DNA sequence in the germplasm of Huso dauricus. The specific sequence of a naturally occurring DNA, is not patent eligible. See, e.g., Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) (The newly discovered location of BRCA1 and BRCA2 genes in the human genome is not patent eligible). See also Ariosa Diagnostics, Inc. v. Sequenom, 788 F.3d 1371, 1373, 115 USPQ2d 1152, 1153 (Fed. Cir. 2015) (Court rejected Sequenom's argument that "implies that the inventive concept lies in the discovery of cffDNA is plasma or serum." That discovery is a natural phenomenon.)
The correlation between a species-specific DNA sequence, and the species comprising such a DNA sequence, reflects a naturally occurring biological correlation and is thus a naturally occurring relation.
In conclusion, the claims recite laws of nature and natural phenomena.
Step 2A Prong 2- Whether the Claim Recite Additional Elements that Integrate the Judicial Exception into a Practical Application: No. The claim does not integrate the judicial exception into a practical application. For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must “transform the nature of the claim” into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981.
Here, claim 2 broadly recites "using" a sturgeon germplasm molecular marker and "identifying" a sturgeon germplasm of interest based on the sturgeon germplasm molecular marker. The step is recited at a high level of generality and reflect extra-solution activities for data gathering, without any additional elements that impose a meaningful limit on the judicial exception. See MPEP §2106.04(d). Thus, the method step merely observes the judicial exception and do not integrate it into a practical application.
It is now well settled under Federal Circuit case law that the use of conventional techniques in a standard way to observe nucleic acids in a biological sample is not eligible for patentability under 35 U.S.C. § 101. CareDx, Inc. v. Natera, Inc., 40 F.4th 1371, 1377 (Fed. Cir. 2022). Therefore, to impose a meaningful limit, a claim must do more than simply apply the natural law with methods/approaches that are known in the art.
Step 2B- Whether a Claim Amounts to Significantly More: No. In this instant case, the claims, when considered as a whole, do not recite any inventive concept with additional elements that amount to significantly more than the judicial exception.
Claim 2 does not recites any additional element with markedly different characteristics that significantly modify or use the naturally occurring correlation in a manner that amount to "significantly more". Methods for species identification of sturgeon germplasm using DNA markers, utilizing molecular assays such as PCR with primers, is well-known in the art since 1998 3.
The dependent claim 5 does not recite additional elements that amount to significantly more than the judicial exception, as it recites testing genomic DNA, which further describes the judicial exception and represents mere general linkage of the judicial exception to the additional elements in the claims (MPEP § 2106.05(h)).
In conclusion, the claims 2 and 5 are not patent eligible under 35 U.S.C. 1014.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2, 5-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Yan 5(Yan et al. InDel DNA Markers Potentially Unique to Kaluga Sturgeon Huso dauricus Based on Whole-Genome Resequencing Data. Diversity 2023, 15, 689. doi.org/10.3390/d15050689; Published on 18 May 2023) .
Regarding claim 2, Yan teaches a method for identifying a sturgeon germplasm of
Interest (Abstract; Figure 2; Figure 9), comprising
using a sturgeon germplasm molecular marker and identifying a sturgeon germplasm of interest based on the sturgeon germplasm molecular marker (Figure 2; Figure 9; page 10, conclusion, “Based on the InDels identified from whole-genome resequencing data, we have developed a series of tools for the identification of Kaluga sturgeon and related hybrids using both dominant and co-dominant markers.”),
wherein the sturgeon germplasm of interest is Huso dauricus or a hybrid of Huso dauricus and other sturgeons (Abstract; Figure 9) , and
the sturgeon germplasm molecular marker is a molecule having a nucleotide sequence of more than 10 consecutive nucleotides in the DNA molecule of SEO ID NO: 1 (Supplementary Information, Figure S1, the red underline marks the specific insertion of H.dauricus, which mostly overlaps with SEQ ID NO: 1, staggered by one nucleotide base).
Regarding claim 5, Yan teaches testing genomic DNA of a test sturgeon for the sturgeon germplasm molecular marker, and determining the test sturgeon is the sturgeon germplasm of interest, wherein the sturgeon germplasm of interest is Huso dauricus or a hybrid of Huso dauricus and other sturgeons (Figure 2).
Regarding claim 6, Yan teaches performing PCR amplification with the genomic DNA of the test sturgeon as a template by using a Hdau216p primer pair (Figure 2),
determining that the test sturgeon is the sturgeon germplasm of interest by obtaining an 216bp amplification product by the Hdau216p primer pair (Figure 2),
wherein the 216bp amplification product is the sturgeon germplasm molecular marker (Supplementary Information, Figure S1),
the sturgeon germplasm of interest is Huso dauricus (Figure 2) or a hybrid of Huso dauricus and other sturgeons , and the Hdau216p primer pair consists of a primer of SEQ ID NO: 4 (Table 1, Hdau216p forward) and a primer of SEQ ID N0:5 (Table 1, Hdau216p Reverse).
Regarding claim 7, Yan teaches performing PCR amplification with the genomic DNA of the test sturgeon as a template by using a Hdau1951 primer pair(Figure 2),
determining that the test sturgeon is the sturgeon germplasm of interest by obtaining an
195bp amplification product by the Hdau1951 primer pair (Figure 2), wherein the 195bp amplification product is the sturgeon germplasm molecular marker (Supplementary Information, Figure S1), the sturgeon germplasm of interest is Huso dauricus (Figure 2), and
the Hdau1951 primer pair consists of a primer of SEQ ID NO: 6 (Table 1, Hdau195l forward) and a primer of SEQ ID N0:7 (Table 1, Hdau195l Reverse).
Regarding claim 8, Yan teaches performing PCR amplification with the genomic DNA of the test sturgeon as a template by using a Hdau1951 primer pair(Figure 2),
determining that the test sturgeon is the sturgeon germplasm of interest by obtaining a 195bp amplification product and a 145bp amplification product, respectively, by the Hdau1951 primer pair (Figure 2b, lane 8-12), wherein the 195bp amplification product and the 145bp amplification product are indicative of the presence of absence of the sturgeon germplasm molecular marker (Figure 2b), the sturgeon germplasm of interest is a hybrid of Huso dauricus and other sturgeons (Figure 2b, lane 8-12), and the Hdau1951 primer pair consists of a primer of SEQ ID NO: 6 (Table 1, Hdau195l forward) and a primer of SEQ ID N0:7 (Table 1, Hdau195l Reverse).
Regarding claim 10, Yan teaches using a set of primer pairs comprising
a Hdau216p primer pair consisting of a primer of SEQ ID NO: 4 (Table 1, Hdau216p forward) and a primer of SEQ ID N0:5 (Table 1, Hdau216p Reverse) and
a Hdau1951 primer pair consisting of a primer of SEQ ID NO: 6 (Table 1, Hdau195l forward) and a primer of SEQ ID N0:7 (Table 1, Hdau195l Reverse),
wherein the sturgeon germplasm of interest is Huso dauricus or a hybrid of Huso dauricus and other sturgeons (Figure 2; Table 1).
Prior Art
Below are relevant prior art not used in rejection but pertinent to the claims or disclosure.
Sturgeon species identification, including the identification of H. dauricus and its hybrids, utilizing molecular methods such as sequencing and PCR is well-known in the art:
See DeSalle (US5786144A - Method and compositions for identification of species origin of caviar; Published on 1998-07-28);
See RU2332463C1 - Oligonucleotide primer set for defining species of sturgeons and products thereof; Published on 2008-08-27; attached copy has English translation;
See CN112831573A - A kind of SNP primer and detection method for sturgeon germplasm identification; published on 2021-05-25; attached copy has English translation;
See CN105002170A - Amur sturgeon germplasm molecular marker identification kit and application thereof; Published on: 2015-10-28; attached copy has English translation;
See Barmintseva AE, Mugue NS. [The use of microsatellite loci for identification of sturgeon species (Acipenseridae) and hybrid forms]. Genetika. 2013 Sep;49(9):1093-105. Russian. doi: 10.7868/s0016675813090038. PMID: 25486777;
See Havelka et al. Nuclear DNA markers for identification of Beluga and Sterlet sturgeons and their interspecific Bester hybrid. Sci Rep 7, 1694 (2017).
See Hu et al., Species Identification of Caviar Based on Multiple DNA Barcoding. Molecules. 2023 Jun 28;28(13):5046. doi: 10.3390/molecules28135046. PMID: 37446706; PMCID: PMC10343275;
See Chandra et al., "Trends in aquaculture and conservation of sturgeons: A review of molecular and cytogenetic tools." Reviews in Aquaculture 13.1 (2021): 119-137;
See Liu et al., The complete mitochondrial genome of the hybrid sturgeon of Huso dauricus (♀) × Acipenser schrenckii (♂). Mitochondrial DNA B Resour. 2017 Jan 11;2(1):11-12. doi: 10.1080/23802359.2016.1275838. PMID: 33473698; PMCID: PMC7800027.
Conclusion
Claims 5-8 are objected to; claims 2, 5-8 and 10 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIAN NMN YU whose telephone number is (703)756-4694. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIAN NMN YU/Examiner , Art Unit 1681
1 Claims 1, 3 and 9 are withdrawn as being drawn to non-elected groups I and III.
2 germplasm: germ cells and their precursors serving as the bearers of heredity
(see www. merriam-webster.com/dictionary/germplasm; Archived Apr 23, 2021 on WaybackMachine)
3 See DeSalle (US5786144A - Method and compositions for identification of species origin of caviar; Published on 1998-07-28);
See RU2332463C1 - Oligonucleotide primer set for defining species of sturgeons and products thereof; Published on 2008-08-27; attached copy has English translation;
See CN112831573A - A kind of SNP primer and detection method for sturgeon germplasm identification; published on 2021-05-25; attached copy has English translation;
See CN105002170A - Amur sturgeon germplasm molecular marker identification kit and application thereof; Published on: 2015-10-28; attached copy has English translation;
See Hu Q, Pan Y, Xia H, Yu K, Yao Y, Guan F. Species Identification of Caviar Based on Multiple DNA Barcoding. Molecules. 2023 Jun 28;28(13):5046. doi: 10.3390/molecules28135046. PMID: 37446706; PMCID: PMC10343275.
4 Claims 6-8 and 10 are not rejected under 35 U.S.C. 101 because they require specific combinations of primers that are not considered well-known, routine and conventional in the art.
5 Yan qualifies as prior art, because its publication date in May 2023 precedes the currently effective filling data in December 2023. Additionally, Yan includes additional author (Hailiang Song) other than the inventors in this present application.
Prosecution Insights